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spk11: Welcome to this Novo Nordisk call regarding our earnings for the first nine months of 2021 and outlook for the year. This call follows the early announcement of the high-level results and race guidance published on Friday last week. I'm Lars Rurgard Jorgensen, the CEO of Novo Nordisk. With me today I have Chief Financial Officer Carsten von Knusen, Executive Vice President and Head of Commercial Strategy and Corporate Affairs Camille Sylvestre, Executive Vice President and Head of North America Operations, Doug Lange. And finally, Executive Vice President and Head of Development, Martin Holst Lange. All presenters will be available for the Q&A session. Today's earnings release and the slides for this call are made available on our website, noahnordish.com. Please note that this call is being webcasted live and a recording will be made available on NOAH North's website. The call is scheduled to last for one hour. Please turn to the next slide. The presentation is structured as outlined on slide two. Please note that all sales and operating profit growth statements will be at constant exchange rates unless otherwise specified. The Q&A session will begin in about 25 minutes. Please turn to slide three. As always, I need to advise you that this conference call will contain forward-looking statements. Such forward-looking statements are subject to risk and uncertainty that could cause actual results to differ materially from expectations. For further information on the risk factors, including the uncertainties around COVID-19, please see the company announcement for the first nine months of 2021 and the slide prepared for this presentation. Please turn to the next slide. In the first nine months of 2021, NorNoisk has progressed on all four dimensions of our strategic aspirations. I would like to highlight a few today. Within purpose and sustainability, we have expanded the Changing Diabetes in Children program. It now includes three additional countries, Indonesia, Pakistan, and Peru, to reach a total of 18 countries included in the program. This will support our aspiration of reaching 100,000 children and young people living with type 1 diabetes in low-resource settings by 2030. Today, the program is providing free care to 30,000 children, adolescents in low- and middle-income countries. Within our Circular for Zero strategy, we are excited that NorNoisk has received an award at the Climate Week in New York City. The award was given for our work in accelerating the global transition to 100% renewable energy. Martin will come back to key milestones within R&D, but I would like to briefly share my perspectives. With the initiation of two Phase III programs within obesity and other serious chronic diseases, we now have ongoing late-stage clinical trials within all of our therapy areas. The Phase III initiation with Siltivacumab demonstrated our ability to successfully integrate the late-stage assets we acquired from Covetia Therapeutics in 2020 into our internal clinical development programs. For commercial execution, we have progressed on all three strategic aspirations. Specifically for obesity care, the initial U.S. demand for Vigovi has significantly exceeded our expectations and underscored the high unmet need for people living with obesity. Camilla and Doug will elaborate further on obesity and provide details on our other therapeutic areas later. Lastly, leaving financials to Carson, we are pleased with the sales growth of 13% and operating profit growth of 12% in the first nine months of 2021, both measured in constant exchange rates. With that, I'll give the word to Camille for an update on commercial execution.
spk16: Thank you, Lars, and please turn to slide 5. In the first nine months of 2021, our total sales increased by 13%. The sales increase was driven by both operating units with international operations growing 13% and North America operations also growing by 13%. GLP-1 sales increased 30%, driven by North America growing 24% and international operations growing 47%. Insulin sales increased by 2%, driven by 6% growth in international operations, partially offset by an 8% sales decline in North America operations. The U.S. insulin sales declined by 9%, driven by a decline in volume and realized prices, the latter driven by channel and payer mix, as well as rebate enhancements. Obesity care sales grew 49% overall. In international operations, Saxenda sales grew 51%, and in North America operations, obesity care sales grew 48%. In the U.S., obesity care sales grew 49%, driven by both Saxenda and Vigovii. Biofarm sales increased by 4%, driven by North America operations growing 6%, and international operations growing by 3%. Please turn to slide 6. In line with our strategic aspiration of reaching one-third of the diabetes value market by 2025, our sales growth of 13% is faster than the overall diabetes market, and hence we have improved our market share by 0.7 percentage points, to 29.9%. This increase reflects GLP-1 growth of 30% and market share gains in both operating units. Currently, USMPIC has been launched in 67 countries and Rebelsus in 23 countries. Please turn to slide seven. In international operations, diabetes care sales increased by 14% in the first nine months of 2021, driven by all geographies and therapy areas. GLP-1 sales increased by 47% in the first nine months of 2021. Novo Nordisk remains the market leader in international operations with a GLP-1 market share of 57.5%, reflecting an increase of 4.7 percentage points compared to one year ago. This is driven by share gains across geographies and overall GLP-1 share of growth in international operations of 73.6%. Please turn to the next slide. BioPharm sales grew by 4% in the first nine months of 2021. This was driven by 6% sales growth in North America operations and 3% sales growth in international operations. Rare blood disorders grew by 7%, driven by uptake of our launch products, Espirop and Refixia, as well as Novo7 and Novo8. Specifically, hemophilia A products grew by 23%, hemophilia B sales by 26%, and NOVA7 by 2%. Where endocrine disorder sales were flat, the unchanged sales reflect international operations increasing by 6%, offset by North America operations decreasing by 10%. And now to Doc for an update on US GLP-1 and obesity care.
spk04: Thank you, Camilla. Please turn to the next slide. The U.S. GLP-1 volume market growth is around 30%, comparing Q3 of 2021 to Q3 of 2020, driven by once-weekly injectable GLP-1s as well as Rebelsys. Novo Nordisk's new-to-brand market share leadership is now 63.7%, driven by continued uptake of Ozempic and Rebelsys. Additionally, Ozempic remains the NBRX market share leader within the injectable GLP-1s and, measured on total scripts, Novo Nordisk remains the market leader with more than 50 percent market share. Please turn to the next slide. In the U.S., Rebelsys' total prescription trajectory continues to steadily increase, now above 40,000 prescriptions per week. Since mid-May, our sales force has been fully back out in the field, and Rebelsys was the second largest contributor to growth for Novo Nordisk in the first nine months of 2021. And if you look at the U.S. specifically, Rebelsys accounted for 36 percent of the growth in the first nine months of 2021. Furthermore, leading indicators such as prescriber breadth, HCP awareness, and sourcing from outside the GLP-1 class remain encouraging. Importantly, we are confident in the product and its long-term potential. Don't forget that within the Pioneer Program, Rebelsys demonstrated itself as the most efficacious OAD on the market as measured on A1C and weight. Now, outside of the U.S., Rebelsys now has been launched in 22 countries, with one key market being Japan, where Rebelsys has reached a 0.9% modern OAD value market share. While underlying parameters are on track, it should still be noted that Japan was in a third COVID-19 lockdown until the end of September, which has made it difficult for patients and sales forces alike to reach doctors. Please go to the next slide. Globally, obesity care sales increased by 49% with 48% growth in North American operations and 51% in international operations. As Lars mentioned earlier, the U.S. launch of Ogovi has significantly exceeded our expectations, underlying the high met needs for people with obesity. This has put the supply chain under pressure. and patients may temporarily experience a delay in getting prescriptions filled throughout 2021. We continue gradual increase in supply and expect to be able to meet demand in early 2022, of course, depending upon demand. The initial feedback from patients and prescribers continues to be encouraging. Nineteen weeks after launch, Wegovy has already surpassed 670 weekly script levels, reaching around 17,000 scripts per week. More than 70% of Wolgovy prescriptions are new to the anti-obesity medication class. Thereby, Wolgovy is expanding the branded anti-obesity market. Market access has progressed since launch, and three national payers have now unblocked Wolgovy from their national formulary. We are excited to share that commercial formulary access is now around 60% for Wolgovy, compared to around 80% for Saxenda. Outside the U.S., Wagovi has been submitted for regulatory review in Japan, and we expect a decision from EU authorities before year's end. Now over to you, Martin, for an update on R&D.
spk06: Thank you, Doug. Aligned with our corporate strategy to strengthen treatment options in obesity and addressing an identified unmet need, we have initiated the first of three trials in the Global Phase 3a OASIS program, which is meant to enroll approximately 1,000 patients in total. The 68-week OASIS-1 trial will investigate the efficacy and safety of one's daily oral Tamaglutide 50 mg in 660 people with obesity or overweight together with comorbidities. Our expectation is to achieve an efficacy and safety profile similar to that of week 0. Within other serious chronic diseases, we are taking an important step to establish a stand-alone presence within cardiovascular diseases. specifically within atherosclerotic cardiovascular disease, or AACVD, a significant residual unmet need remains, despite the availability of many treatments. Therefore, in September of 2021, we initiated the phase 3 cardiovascular outcomes trial called SUSE, with a CVD asset that we have named celtivecumab, which we acquired from Covidia back in 2020. In brief, siltivekimab is a monoclonal antibody directed against IL-6 and is aimed to address the residual inflammation in patients with ASCVD as well as chronic kidney disease. The trial will assess the efficacy and safety of subcutaneous siltivekimab 15 mg in around 6,200 patients with established ASCVD, chronic kidney disease, and systemic inflammation. This will be an event-driven trial, which is expected to complete in 2025. As we've previously discussed, and as Lars also alluded to, with the initiation of these two Phase III programs in the third quarter, we now have ongoing Phase IIIa clinical programs within all of our therapy areas. Please turn to the next slide. Now turning to the high-level R&D milestones, we start with the third quarter of 21. Within diabetes, we completed a phase 1 trial with glucose-sensitive insulin called NN1845. In the trial, the acid appeared to have a safe and well-tolerated profile and demonstrated proof of principle of glucose-sensitive properties. We are currently evaluating further development of glucose-sensitive insulins to optimize the pharmacokinetic properties of this acid. It goes without saying that this is an area that requires multiple shots on goal, and we are actively exploring these in our research area. Within other serious chronic diseases, as we've just discussed, we initiated Phase III cardiovascular outcome trial for the Siltivacumab. Within NASH, we completed a Phase II trial in Q3, investigating the efficacy and safety of semagnatide 2.4 mg in people with NASH F4 cirrhosis. While the trial demonstrated significant and clinically relevant reductions in the level of steatosis, it did not manage to demonstrate an effect of semaglutide in the primary endpoint of fibrosis in this population. Semaglutide appeared to have a safe and well-tolerated profile. A consequence of these results, we've decided that semaglutide will be further developed for F4 cirrhosis patients as part of combination therapy only. To this effect, two combination trials have been initiated within NASH F4, one as previously mentioned in collaboration with Gilead, and one in combination with our internal assets. It's important to mention, and as previously discussed in Q2, that Tamaglutide in monotherapy appears to be a very effective and potentially interesting treatment for patients with NASH F2 and F3, and this is currently being investigated in Phase III under an FDA breakthrough designation. Towards the turn of the year, we expect an opinion from the EU on Tamaglutide 2.4 mg in obesity and Osempic 2.0 mg in diabetes. Within BioPharm, we expect results from the Phase III program for somopacetam in children, as well as results from cohorts of the ongoing combined Phase I-II trial with MyMed. As planned, we will initiate baselining for the Phase III program with MyMed in Q4 and at risk, while still awaiting the full results from the Phase I-II trial. This aligns with the innovative and fast, as well as ambitious clinical development program that we have previously talked about for MyMed. In the first half of 2022, we expect Phase IIIa results for insulin, iacodec, and diabetes, as well as for concizumab, and the full results for MyMADE and BioPharm. We also expect to see the initiation of the Phase III program for capricema and obesity. With that, over to you, Karsten.
spk08: Thank you, Martin. Please turn to slide 14. In the first nine months of 2021, sales grew by 8% in Danish kroner and by 13% at counter-exchange rates. The gross margin declined to 83.0% compared to 83.8% in 2020. The decline reflects a negative currency impact of 0.5 percentage points, lower realized prices in the U.S. and amortization of intangible assets related to the acquisition of Hemisphere Technologies in 2020. These are countered by a positive product mix driven by increased GLP-1 sales and productivity improvements in line with the strategic aspiration of driving operational efficiencies. Sales and distribution costs increased by 10% in Danish kroner and 14% at constant exchange rates. The increase is driven by investments in our key strategic priorities, most notably launch activities and promotional spend for Rebelsis and Rosimpic, as well as market development activities for obesity and investments in the U.S. launch of VigoV. Research and development costs increased by 11% in Danish kroner and 13% at concert exchange rates. The increase is driven by pipeline expansion and diversification, including progression of the pipeline within cardiovascular disease and NASH. Administration costs increased by 4% in Danish kroner and 6% at concert exchange rates. impacted by a low spend in the first nine months of 2020 due to COVID-19. Operating profit increased by 5% in Danish kroner and by 12% at currency exchange rates. It was positively impacted by the amortization of the priority review voucher for Vigovi in the U.S. in the third quarter of 2020. The negative currency impact on operating profit is partly offset by around 1 billion Danish kroner in hedging gains on the net financial items. This compares to a loss of around 1.8 billion Danish kroner in the first nine months of 2020. The gains on hedged currencies primarily relate to the U.S. dollar. Net profit increased by 12% and diluted earnings per share increased by 14% to 15 kroner and 98 euro. Free cash flow was 52.3 billion Danish kroner compared to 41.6 billion Danish kroner in 2020. The increase reflects the higher net profit, timing of rebates in the U.S., and favorable impact from changes in working capital. Further, it is positively impacted by lower intangible investments as related to the acquisition of Covidia Diabetics Impact in 2020. Next slide, please. We now expect 2021 sales growth to be between 12% and 15% at contract exchange rates. The raised guidance is based on the performance seen in the first nine months of the year and reflects expectations for continued sales growth in both international operations and North American operations. The updated outlook reflects higher-than-expected SMPIC market share gains, GLP-1 market growth, and obesity care sales, all mainly in the U.S., It also reflects intensifying competition within both diabetes care and biopharm. Finally, continued pricing pressure within diabetes care, especially in the U.S., is expected to negatively impact sales developments. Operating profit is now expected to grow between 12% and 15%, reflecting the sales growth outlook and continued investments in current and future growth drivers. This includes the continued rollout of Osympic and Rebelsis, the launch of Vigovii, and associated market development activities. Furthermore, additional resources are being allocated to both early and late-stage R&D pipeline activities. Given the current exchange rates, most notably a strengthening of the US dollar, we expect a less negative currency impact for the full year compared to three months ago. Consequently, our reported sales and operating profit growth is now expected to be three and four percentage points lower than at constant exchange rates respectively. For 2021, financial items are now expected to be a gain of around 0.3 billion Danish kroner, mainly reflecting gains associated with foreign exchange hedging contracts. Capital expenditure is now expected to be around 7 billion Danish kroner in 2021. Lastly, free cash flow is increased by 5 billion Danish kroner and now expected to be between 44 and 49 billion Danish kroner. This reflects a favorable impact from higher sales and net profit expectations, timing of U.S. rebates in the U.S. and lower capital expenditure. Based on the increased expectations for cash flow generation in 2021, the Board of Directors has approved an expansion of the 2021 share repurchase program by 2 billion Danish kroner to 20 billion Danish kroner. That concludes the outlook for 2021. Now back to you, Lars, for final remarks.
spk11: Thank you, Carsten. Please turn to the final slide. We are very pleased with the sales growth in the first nine months of 2021. Sales growth was driven by all geographical areas within its national operations as well as North America operations and by all therapy areas. In particular, the sales growth was driven by an accelerated growth of our portfolio of GLP-1 treatments for diabetes and obesity care. The strong financial performance in the first nine months of 2021 has enabled us to raise our outlook for the full year. From an R&D perspective, the two Phase III program initiations within obesity and other serious chronic diseases highlights that we continue to expand our late-stage clinical pipeline. With that, we're now ready for the Q&A. where I kindly ask all participants to limit her or himself to one or maximum two questions. Operator, we are now ready to take the first set of questions, please.
spk18: Thank you. If you do wish to ask a question, please press 01 on your telephone keypad. If you wish to withdraw your question, you may do so by pressing 02 to cancel. Our first question is from Ramal Kapadia of Bernstein.
spk17: Great. Thank you very much for taking my questions, Ramal Kapadia from Bernstein. So can I just first ask a little bit more about 21 guidance and the implications heading into 22? So the top end of the sales range for 21 suggests the potential 4Q sales growth of over 20%. So can you just first discuss the dynamics that could potentially get us to that level of sales growth in the quarter? And then tied to that, What are the implications for this level of growth heading into 22? Outside of the 340 benefit, which annualizes and possibly VBP, are there any other reasons why underlying growth should not be stronger next year, given the Wagobe supply constraints will be resolved? And I'll leave it there.
spk11: Thank you, Vimal and Carsten. While not guiding for 22 yet, can you talk a bit to landing this year and some of the building blocks for how to look at growth for next year?
spk08: Yeah, absolutely. Thank you, Imelda, for that set of questions. So first, looking at 2021, as you saw, then we delivered 13% sales growth in the first nine months. And mathematically, of course, it's hard to move the needle with only one quarter to go. So as a starting point, I think you should anchor yourself in the 13% and then look at the run rate we achieved. we delivered in the third quarter benefiting from the GLP-1 acceleration as well as the obesity performance. So for 2021, I think the starting point is more around the midpoint of our guidance range being around 13.5%. The reason why we choose to go with a slightly broader than normal guidance range is basically the volatility we've seen in our business over the past few years as well as also the volatility linked to the obesity business. So that's basically the reason for the guidance range. But the starting point would be the midpoint of the range. Then moving into 2022, then from a strategic point of view, we are pursuing a growth-focused strategy. And when you look at the growth rate for Norske as a company, we are clearly outpacing the industry, potentially close to double up in terms of top-line growth compared to the industry at large. So clearly growth is a top priority for us as a company. 2021 was an exceptional year for us in terms of growth rates. Everything has pretty much gone well. So really a highly successful year to start on. And we do continue to pursue growth into 2022 at a very attractive level, driven by our GP1 business as well as our obesity franchise. In terms of puts and takes, I would caution you in terms of a couple of specific aspects. First of all, we are currently getting closer to... to a conclusion on the volume-based procurement tender situation in China. We have not yet received the final bidding documents, but we expect to receive them shortly. And with insulin in China constituting to the tune of 9% of group sales, then this tender situation, we do expect to have a significant negative impact on our group sales in 2022 as one piece. Secondly, what we do benefit from in 2021 is the 340B distribution policy change we did in the US markets, where we basically restricted the distribution under the 340B program to covered entities. There we are getting a benefit. And as we've said in prior quarters, and there are no changes to that this quarter, then we're getting a benefit. It's less than 3% of U.S. sales, but I'm just reminding you that even 3% of U.S. sales is 1.5% of group sales. So with that in the base, we would not get that growth benefit in 2022. And then finally, what we're benefiting from now is also an acceleration in the GH1 market growth. in diabetes in the U.S., but also outside the U.S. We've seen in Q3, as you heard, to the tune of 30% volume market growth in the GF1 segment. That acceleration and looking at some of the more weekly trends, we do expect that acceleration to slow down and getting back to a more normalized growth level in the overall GF1 market when we get into 2022. So you have to adjust for those factors, but needless to say, we do continue to push for attractive growth for our shareholders.
spk11: Great, thank you. Thank you, Carsten. Thank you, Carsten. Thank you, Rimal. Strong growth for a couple of factors to begin for the short term. Next set of questions, please.
spk18: Thank you. Our next question is from Peter Verdelt of Citigroup. Please go ahead. Your line is open.
spk14: Thank you, people at Old City. Two questions. Firstly, just Camilla or Doug, appreciate the update and comments on reimbursement access. Just one clarification. Should we still be thinking that when it comes to WeGoVie prescriptions, 50% are reimbursed and 50% are effectively given away as part of the Novo assistance programs? Wanted to make sure that that's the right way of thinking about it going forward. And then secondly, For Lars and Carsten, just any comments you're willing to give, realizing that things are subject to change, but on the drug pricing amendments announced overnight in the U.S., if enacted and the donut hole discount is removed. That looks like a big win for Novo. But more problematic long-term would be mandatory price cuts for semaglutide before the IP expires. So realize nothing is set in stone. I realize you're not going to speculate, but I think it would be remiss of me not to ask you for some initial thoughts on those developments. Thank you.
spk11: Thanks, Peter, for those questions. Doug, initially on, say, the book of business developments, in the U.S. on Regovi, and then I'll cover the drug price reform afterwards.
spk04: Yeah, thanks, Peter, for the question. So overall progress has been made, and we're happy with the progress with the overall commercial formulary access for Regovi. And broadly speaking, we're looking at 40 to 60, 40 percent covered, 60 percent not covered.
spk11: Good. And you alluded a bit to it, Peter, yourself, that it's difficult to speculate about the U.S. health care reform. Just noting over the past couple of weeks, I think rhetoric has been going forth and back. So we would like to have, say, the final text before we start assessing the impact on us. Having said that, though, we strongly welcome anything that helps the patient's out-of-pocket situation because the complexity of the system ends up with a lot of patients struggling. As you know, we a couple of years back, put some affordability programs in play to take some of that pain away. And there was also a cost to that. So anything that can smoothen out the system and help patients better is obviously good for the patient, but I think it's also going to be good for our business. But we need to see the final text before we comment on that. So hopefully when we talk a quarter of an hour, there's more clarity on that. Thank you, Peter. Next set of questions, please.
spk18: Thank you. Our next question is from Simon Baker of Redfern. Please go ahead. Your line is open.
spk03: Thanks for taking my questions. Two, if I may, please. Firstly, on biopharma, the quarter did look a little weaker than consensus was expecting. You did allude to Chinese destocking impacting haemophilia. I just wonder if there were any other factors you would highlight, maybe given the exposure to the tender market in biopharma, anything of tenders that were different to what we were expecting. And then secondly, on CAPEX, I see you've just trimmed the CAPEX guidance slightly for 21. I just wonder if you could give us any color on that and any implications for the CAPEX outlook going forward into 22 and beyond. Thanks so much.
spk11: Thank you, Simon. So two questions to you, Carsten. Firstly, on the biopharm performance in the third quarter, not slower than what we saw in the beginning of the year, And then CapEx also a bit lower compared to what we've seen before. Any perspectives on that?
spk08: Yeah. Thank you, Simon, for that set of questions. And starting out with BioPharm, I'd just like to remind you that the BioPharm business is a more volatile business than the rest of our businesses in diabetes. So kind of over-interpreting on the quarters is dangerous on BioPharm. So you should more be looking at biopharm on a year-to-date basis, growing some 4%, which we're actually very, very satisfied with. To give you a little bit of flavor on the quarter, though, I'd say we did have some changes in shipment timing on the hemophilia side in international operations impacting the quarter. And in the U.S., we did have some changes minor adjustments to rebate estimates that impacted our growth hormone franchise. So again, the more kind of informative measure would be our year-to-date performance, which we're very satisfied with. As to CAPEX, it's a slight fine-tuning. There's nothing substantive around it. The adjustment is basically linked to phasing of the execution of our cash burn on our ongoing CAPEX programs. So there are no No delays or anything in our programs. It's purely, you could say, exact timing on cash flow. Nothing more than that. Great. Thanks so much.
spk11: Thank you, Carsten. And on CapEx, it's clear that with the momentum we see right now, we are probably going to spend more money compared to less money on CapEx because it's really, really strong growth. And obviously, we need to make sure we have capacity to support that. Thank you, Simon. Next set of questions, please.
spk18: Thank you. Our next question is from Michael Leuchten of UBS. Please go ahead. Your line is open.
spk09: Thanks very much. It's Michael Leuchten from UBS. Two questions, please. One, Karsten, just going back to the guidance, the implied OPEX growth in the fourth quarter is pretty punchy, certainly as the year has progressed due to you seem to sort of have walked up the OPEX phasing into the business as the top line outlook has improved as well. In the fourth quarter, where is that incremental investment going and what implications does that have as a run rate as we think about 2022, if you could? And a question for Doug, looking at the value of the volume of Rydell's, it looks like I've stepped up. I presume that's the copay card rolling off. If that's the case, timing is interesting here. If Ribelsis really is the product that longer term is sort of meant to carry the torch, why would you hold the co-pay program at this point in time if that's indeed what is driving the value of the volume? Thank you.
spk18: Ladies and gentlemen, please hold. We're experiencing some technical difficulties. Ladies and gentlemen, thank you for your patience. We have now reconnected. Our question was from Michael Leuchten of UBS.
spk11: So Michael, I'm not sure when the technology went down. So did you hear Carsten's answer and did you hear Doug's answer?
spk09: No, sorry. It cut off entirely before that.
spk11: Okay. So let's try again. So the first question was on guidance for OBEX growth in fourth quarter. So Carsten, if you can talk to that. And then secondly... Doug will talk to how we see Rebels was launched and also how we look at co-pays, etc.
spk08: Yeah, absolutely. Thanks, Michael, for that set of questions and apologies for a technical glitch. So when you look at OPEX into the fourth quarter, it's, of course, the same principle we're applying for our resource allocation. And just the main nuts and bolts is basically we continue to invest in R&D We are now exceeding 35,000 annualized patients on clinical trials, so all-time high in global development. So continued increasing investments in R&D, which, of course, you should expect into 2022 also. And in our commercial investments in S&D, we are continuing to invest in growing and expanding our GF1 business in diabetes as well as market development investments as well as we go with all activities in obesity. So the same principles applies, and in terms of run rate into the fourth quarter, I don't see it as too dissimilar from the run rate we've seen thus far this year. And then, of course, you know, you shouldn't technically do your forecast, as I know you know, based on one quarter into next year, but it's the same principles that we're rolling into next year. So aggressive growth... investments in commercial and expansion into a broader and more diversified pipeline in R&D.
spk11: Thank you, Karsten. Doug, on Rebelsys' performance in the U.S.
spk04: Again, Michael, thank you again for that question. Overall, we do consider it still a very successful launch for Rebelsys overall. And despite some of the lockdowns that we've experienced with COVID-19 last year into this year, as I've mentioned, the field force is back in since mid-May. we still consider it a successful launch. Are we where we want to be? Well, again, based on what I said earlier, we can't forget that through the Pioneer Program, Rebelsys demonstrated itself as the most efficacious OAD in the market. So we're still very bullish on the long-term aspect of what Rebelsys can do. And we have a lot of leading indicators which help us be encouraged with this, whether it's, again, if you look at the growth overall, as we said, it was the second biggest growth driver for the company, 36% of the growth in the U.S., We delivered over 180% growth, but more importantly, other leading indicators such as breadth and depth, brand awareness, brand preference. We're still seeing over 80% of the business come out of the GLP-1 category outside of the GLP-1 category. Other things like, you know, we're doing 40,000 prescriptions per week. And again, we have a significant number of writers over 45,000. So these are all indicators that we're still very bullish on what we can do over the long haul.
spk11: Thank you, Doug. Thank you, Michael. Next set of questions, please.
spk18: Thank you. Our next question is from Emmanuel Papadakis from Deutsche Bank. Please go ahead. Your line is open.
spk02: Thank you for taking the question. Maybe I could just come back on. We'll go over to 4060. Sounds like it's, I guess, you could say deteriorated of anything from Q2, as in there is more subsidized product out there. How is that evolving through Q4 when you expect we'll be at a stage that the co-pay support is fully rolled off? Is that likely to be why it's front-ended Q1? And what kind of impact are you expecting that to have on the launch once you have normalized the supply situation? And then just a question on the commercial access. You disclosed it the first time at 60%. Can you talk to us a little bit about the levels of utilization management within that? Are they similar to Saxenda? Are you seeing any significant differences, and how do you expect those to evolve into 22 as well? Thank you.
spk11: Thank you. Let me try to address the go-wee. So our strategic priorities have been to really mobilize patients to seek care, to get physicians to prescribe anti-obesity medicine and get payers to reimburse the go-wee. And you shouldn't get too deep into short-term commercial tactics in how we do that and make that a proxy for the future. Because the fact that we have had this bridging program has indeed helped us to mobilize patients and get physicians to prescribe it. And the clinical profile of the GOI has attracted a lot of attention from the payers, so now we have the three big PBMs supporting it. And then you can say as launch progresses, we can gradually start considering a different promotional mix. After six months, you can, for instance, do DTC in the U.S., which you cannot do in the beginning. So there you need to use the co-pay or the bridging program to gain patient experience. So we are quite agile in how we look at this promotional mix and short-term programs Book of Business, whether it's on commercial covered patients or it's free patients, doesn't really matter for us. It's about getting this market and the brand going. And from everything we can see, we are succeeding in doing that. So, Doc, a few more perspectives on how the commercial access works.
spk04: Yeah, so just to answer, Emmanuel, the very specific question you had, it is very similar to utilization management to Saxenda, and importantly, there's no step-through. So that's important. And overall, again, as I mentioned earlier, we have 60% overall formulary access, and that's progressing nicely. The team is also doing a really nice job in terms of the opt-in component with employers. I can't get any specifics there, but, again, that's progressing nicely. Remember, this is still not considered a standard-listed company. product, formulary products. So we have some work to do there, but the team is working hard. And as Lars mentioned, we have all three major PBMs on board. That's a really good sign. And we have partnerships with several of them in weight management programs, which is also another very good sign. So overall, I think progress is being made.
spk11: Thank you, Doug. Thank you, Emmanuel. Next set of questions, please.
spk18: Thank you. Our next question is from Steve Scala of Cowen. Please go ahead. Your line is open.
spk13: Oh, thank you. You noted that you expect WEGOVI supply to meet demand in early 2022. What level of demand does this imply based on your expected supply? So for instance, is it closer to two times more, 10 times more, or 25 times more? And then secondly, similar question to ones that have already been asked, but a little different version. What percent of the U.S. population can access full coverage of WEGOVI today? And what might that percent be at the beginning of 2022? Thank you.
spk11: So thank you, Steve. So we have our own forecast in how we model demand. And unfortunately, we're not in a position to be able to share that. But we believe that based on how we understand the market, the flow of patients, that we can match that demand. But, of course, we have been surprised initially here, so we do not know much more than you do in terms of what the real demand will be, but we feel comfortable that we can help the patients in need of anti-OBG medicine. And, Doug, on the second question, in terms of which percentage of the U.S. population is within reach of
spk04: Yeah, thanks for the question, Steve. In the end, it's important to note that we still don't have Medicare coverage, so that takes out a significant portion of the population. We're working really hard, and we hope to, at some point, whether it's through the Treat and Reduce Obesity Act or some policy change, another policy change, to open up that. Because as a company, we certainly think that seniors in the U.S. should have access to anti-obesity medications. I mean, that's clear evidence. Today, again, so if you just take a look at the commercial access and where we are, we think around 16 million to 20 million people, patients living with obesity, have access. And, again, our aim is to get that much more like other products, standard listed products. So, you know, our aim is to get much higher, and that's going to take some work. But today, around 16 to 20 million people today.
spk11: Thank you, Doc, and just for thinking about it, Thank you. Steve, next set of questions, please.
spk18: Thank you. Our next question is from Carsten Lombard of SEB. Please go ahead.
spk05: Thank you very much. I have a couple of questions here to Martin, I guess. The OASIS program for Alzheimer's in obesity, you have three trials in this program in total. One China patient, one Japanese patient, one with the European and North American patients combined. Is this a sign that you only need one trial to get this product approved in the U.S. with the North American patients, or can you leverage something else on top of this? And then for SEMA in Alzheimer's, I know it's not so long ago since you actually initiated the Phase 3 trial, but could you maybe share some of the feedback you have had in terms of appetite to get enrolled on this trial in the Alzheimer's community? Thanks.
spk11: Thank you, Carsten. Over to you, Martin, first on OASIS trial design, number of trials needed, et cetera.
spk06: Yep, absolutely. So as you mentioned on OASIS, it's a fairly slim program, 1,000 patients in total, which obviously also indicates that we've agreed with regulatory authorities that we need to bridge based on the data that we already have on semaglutide. We are in the good position that we're both on subcutaneous and oral And also on the different doses, now also on oral, have a lot of data with which we can bridge to satisfy the regulatory requirements. On the Alzheimer's trial, it's still early days. As you can probably imagine, we are screening a great number of patients, but the screening period in and of itself is three months. So at this point in time, what we see is that the sites that are open and up and running actually screening and recruiting to the level where we would expect them to be or a little bit above.
spk11: Thank you, Martin. Very encouraging. And thank you, Carsten, for those questions. Next set of questions, please.
spk18: Thank you. Our next question is from Martin Parkoy of Danske Bank. Please go ahead.
spk10: Martin Parkoy, Danske Bank. Also two questions. First, for Lars, you quoted on on various news media about China, that you expect this to be a one-time effect with a potentially significant haircut to pricing. But how do you state now that it will only be a one-time effect? For example, going into right now, you're seeing 35% growth in your long-acting insulin franchise in China. Do you feel comfortable that after a big price cut, then you can continue on this trend journey with Traceeba in China or isn't that risky this could be a controlled tender market and then second question I think will be for Doc just again on the GOI and coverage and stuff like that in US you say 60% are on it for free but you also call it of course it's called the bridge card because you're making a bridge onto this patient hopefully should get coverage But I also know that some are able to get the drug, even though they don't fit into that category. But how many of these 60% will actually have coverage when their six-month period ends?
spk11: Thank you, Martin, for those two questions. And let me start on China. Obviously, I don't know for sure what will happen in China because I'm not in charge of that. But if you look at the whole intention about the VBP, that was to bring the pricing of drugs in China down to the international level. And there are a number of drug categories. So I feel that it's a rational attempt by the authorities in China to get to the right price level. And then there's a keen interest in bringing innovation to China, accelerated regulatory review, etc., And of course, if it turns into a very hostile pricing environment, I don't think the authorities are creating an attractive market for innovation. So at least for now, we feel comfortable about that. And Doug, once again, on WeGoWe.
spk04: Yeah, thanks, Martin, for the question. So the intent of any of these early initiations or bridge programs is to build awareness, get initiation of use. Physicians can see results immediately. And again, for us, the bridge program was designed to be screened for people that had coverage. Now, again, it's not a perfect system. Based on the demand, it was probably one of our most successful programs that we've launched. But we don't have the exact specificity to know how many coming off that program would exactly have coverage. But again, the intent was you start them, and then they would have coverage when they come off of it.
spk11: Thank you, Doug.
spk04: Thank you, Martin.
spk11: Next set of questions, please.
spk18: Thank you. Our next question is from Joe Walton of Credit Suisse. Please go ahead.
spk12: Thank you. I've got two questions. If we could go back to your confidence in the lack of, in the fact that the GLP market growth of 30% will ease off next year. I just wonder why that is. Is it just the law of large numbers or is it perhaps that particularly for your products you're seeing some extra obesity use with Ozempic, which will presumably disappear next year when Wegovy comes in. So we need to be sure that we're not double counting. And secondly, I wonder if you could tell us a little bit about how long people are staying on Ozempic these days. I think the data that we have is that the stay rate on all of the GLPs is still pretty poor, less than six months or so for many patients. Have you been able to make some progress there? Thank you. Good.
spk11: Thank you, Joe. Carsten, first, obviously difficult to predict the future of GLV-1 market growth. So can you put a bit more color on your comments that we are right now seeing a higher level than we have seen in the past? And then Camilla can talk to State Time on Ocempic.
spk08: Yeah. Thanks, Joe, for that question. And, of course, it's a forward-looking statement. The reason why I pulled it forward was when you look at... at actual NBRX scripts on a weekly basis. We saw a significant step up, I'd say, in June or so, if you take the U.S. market data, absolute number of NBRX in the GLP-1 market segment, most notably on Ocempic. After that step up, actually the trend has been fairly similar to what we saw before the step-up. So we don't see a continuous step-up, but more like a normalized growth rate during the third quarter and into the fourth quarter as well. Thank you, Carsten. Camilla, stay time?
spk16: Yeah, so on stay time, we actually do have a stay time that from the latest data we have is close to around, roughly speaking, more than 50 months on OCEMPIC. We do think that, you know, this is in general just a quite significant state time and people are, you know, we know that we can get 80% of people in good control from our clinical trials. So I think that covers that.
spk11: Thank you, Camilla. Thank you, Joe. Next set of questions, please. I think we are homing in on the last set of questions, perhaps two, depending on the lengths of the answers.
spk18: Thank you. Our next question is from Kerry Holford of Barenburg. Please go ahead.
spk01: Thank you. Yes, coming from me, please. Firstly, just going back to Rigobi, I would be interested to see what proportion of the 60% of covered lives have the employer opt-in effectively granted. And also to understand whether you're finding any debate in your pricing and access negotiations for that obesity outcomes data. You know, how much further... Do you think you can expand or go the axis essentially ahead of that readout, I think, at the back end of 23? And then just quickly on NIM8, what is giving you the confidence to move forward to start Phase 3 this quarter ahead of seeing that readout into Phase 1, 2? Thank you.
spk11: Thank you, Kerry. So, Doc, first a perspective on... As I understood it, in the commercial sector, how many employers are opting in?
spk04: So we don't disclose that, but generally speaking, we do have, I would say, a large number of employers that have opted in to where we have coverage today. And our aim is to continue to work. We have a regional account team that's out there every day working hard, as well as an employer team. And again, it's an important component to building the overall access and affordability, quite frankly, over the long haul.
spk11: And if I just should give a very quick answer to the question on the outcome data and health technology assessment, et cetera. So we actually see that payers today with what we can deliver see that there's value in the product. So I don't think we have a situation where we need to see COT data for the case to be intact for weight loss here. And Martin, on MyMate.
spk06: Yes, so as you know, we've designed a fairly ambitious development program where we try to go from first human dose to basically submission in a matter of four years. That requires some assumption, and it requires a little bit of initiating things, including our phase three trial at risk. We do obviously continuously monitor the different cohorts that read out in the ongoing phase one to two study. It basically means that we know about the safety of patients of the drug in that space. And we do also have some preliminary efficacy readouts in the earlier course. So far, we've seen nothing that would discourage us from going into phase three, which is why we are continuing to pursue our plan.
spk11: Thank you, Martin. Thank you, Kerry. And we'll take one final set of questions, please.
spk18: Thank you. Our final question will be from Sachin Jain of Bank of America. Please go ahead.
spk15: Hi there. Thanks for fitting me in. Just a couple of clarification questions, please. So first, to go back to Ry Beltus' sequential growth in the US, to clarification to Michael's question, it grew sales 40% versus prescription volumes 15% sequentially. Just to clarify, do you expect sales to grow ahead of scripts going forward as co-pay programs come off? And secondly, a follow-up on the GLP-1 growth outlook for next year. Noting you have a competitor launch to Zepatide, which you've historically said would accelerate the market. So just to clarify how we think about 22 GLP-1 growth given that new launch? Is that normalized market growth with show loss of competitor, or do you think that product accelerates the market? Thank you.
spk11: Thank you, Sachin. Karsten, can you try to put some color on both questions, both, say, value per script on Rebelsys, and then what more you can give on Jilpo One market outlook?
spk08: Yeah, so thank you, Sachin, for that set of questions. First of all, on Rebelsys in the U.S., and and the delta between Scripps and X Factory and realized ARP. I think the key point is where, as we showed in the earlier slide, then we actually have a very, very stable TRX uptake curve in the U.S., and Doc was talking to that. So I think the more meaningful measure on Rebelsis is basically to look at the stability of the TRX curve, and then individual quarters are impacted, you know, by... it could be minor inventory movements either this year or last year, etc. So I think I would peel that away and say, look at the TRX trending and look at our year-to-date numbers. That's a more reflective way of looking at rebelses. As to GLP-1 market growth, then yes, what we've seen historically is that a launch is beneficial to the market today. But you can say the market has also been benefiting from the Rebelsis launch over the past one and a half years, up to two years or so. So that's what I mean with the normalized market growth. So assuming a Triceratopsite launch mid-next year, that, you know, of course what we've seen in GILP-1 is that it has been a market expansion strategy on our side and also on the Lilly side. I don't know their strategy, but... But presumably it would help expand the markets.
spk11: Thank you, Karsten. Let's sneak in one final, absolute final question or set of questions.
spk18: Thank you. Our final question will be from Richard Fossa of J.P. Morgan. Please go ahead.
spk19: Thanks for taking my questions. I'll just do one. And it's just looking at the obesity franchise in a bit more bigger picture. So how should we think about the development of that franchise? Do you think you could already see the franchise double relative to fourth quarter 20? Given improving Wegovy supply, given what we can see in the script of Wegovy probably doubling in the U.S. and strong continued growth of Saxender ex-U.S., just your thoughts there. Thanks very much.
spk11: Thank you, Richard. So I can unfortunately not go into guiding on obesity. But of course, you raise a good point that we see a very, very strong uptake of Obigobi in the U.S. better than anyone, I would say, have anticipated. It's not based on cannibalization of Saxenda, which is holding up nice in the U.S., and we see that Saxenda is accelerating its position outside of the U.S., so very strong growth, actually to the same degree as we see in the U.S. in its national operations. And we see a number of markets where obesity is moving in, being reimbursed because healthcare systems acknowledge the need for having anti-obesity medicine, not least coming out of a pandemic where it's clearly established that living with obesity is a risk factor if you catch COVID-19. So we are very encouraged in terms of the three priorities I mentioned, mobilizing physicians to prescribe, mobilizing patients to seek care, and also increasingly having payers to acknowledge the need for anti-obesity medicine. So I think that holds well for the future growth, and in due time we will clarify with you what our aspirations are, but for now it is at least to double it by 2025, and we feel comfortable we can do that. So with that, thank you all for your participation. This concludes our earnings call. And if you have more questions, feel free to reach out to our investor relations and looking forward to meet you sometime soon in the future. Thank you very much. Bye-bye.
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